The reality of a vaccine used to treat celiac disease has gotten even closer. Researchers working on a vaccine to protect those with celiac from gluten-exposure have successfully moved forward to the next round of clinical trials.
ImmusanT, a Massachusetts biotechnology firm and developers of the Nexvax2 celiac vaccine, recently concluded Phase 1b trials, which tested the safety and tolerability of the vaccine at various doses, from an initial injection to a series of booster shots.
Currently, the only way to manage celiac disease is by adhering to a strict gluten-free diet. This is not only difficult and expensive, but continuing accidental exposure to gluten puts people at significant risk for ongoing intestinal damage and debilitating symptoms. If Nexvax2 successfully completes the additional trials necessary, it could be the first FDA-approved drug to treat celiac disease, and would be a game changer.
Using immunotherapy, Nexvax2 offers a promising approach to celiac disease as it utilizes the body's immune system to effectively vaccinate against the disease.
How Does Nexvax2 Work?
The premise behind Nexvax2 is that if a small amount of the vaccine (containing the harmful protein found in gluten) is given at first and that amount is gradually increased, the immune system will build up resistance to the harmful protein in gluten without any negative effects.
Previous studies have shown that the first dose of the vaccine prompted the immune reaction to gluten, with patients who received Nexvax2 showing activation of T-cells as well as typical celiac disease symptoms. But when treatment ended after twice weekly doses of Nexvax2 for eight weeks, the T-cells were no longer active. Additionally, when patients who had received Nexvax2 ate gluten for three days, the immune reaction was not triggered.
In the recent trial, 38 patients in three groups were given gradually escalating doses of the vaccine or a placebo, followed by maintenance doses that were higher than those tested in earlier studies. The results are being used to create a dosing regimen for a planned Phase 2 study this year.
What Happens Next?
A phase 2 study provides a crucial next step for Nexvax2, that will involve more participants and be designed to determine how well the vaccine works at protecting against gluten exposure, as well as whether the benefits outweigh any risks. ImmusanT will begin recruiting patients for phase 2 later in 2017.
Results of the clinical trials thus far "provide important insights into the optimization dosing and immune monitoring for this new class of drug," the company said in a press release announcing its conclusion. Leslie Williams, ImmusanT president and chief executive officer, commented that "Nexvax2 has the potential to protect against the effects of gluten exposure in patients with celiac disease and improve their quality of life."
Initially, the vaccine would be used to protect against gluten exposure while patients continue a gluten-free diet. But as a second step, ImmusanT is looking to launch a vaccine that would eliminate the need for a gluten-free diet.
Nexvax2 is one of several celiac disease drugs being studied in light of evidence that patients on gluten-free diets continue to have symptoms, intestinal damage or both, and other ongoing research that highlights the significant burden of the diet in general.
Read more about Nexvax2 here.